NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-173619

Registered date:19/06/2017

ZA_VD

Basic Information

Recruitment status recruiting
Health condition(s) or Problem(s) studiedOsteoporosis
Date of first enrollment15/6/2017
Target sample size100
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention name : ZOREDORON acid INN of the intervention : - Dosage And administration of the intervention : I call for more than 15 minutes 5 mg, and, intravenous drip (once a year) Intervention name : eldecalcitol INN of the intervention : - Dosage And administration of the intervention : 0.75 ug is taken for 24 months more than a ZA start date once a day (I cut down at 0.5 ug by the symptom.) Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -

Outcome(s)

Primary Outcomeefficacy The change amount of before prescription starting and the lumber vertebra bone density which is 24 months after prescription
Secondary Outcomeefficacy The following item in before prescription starting and 3 or 6 or 12 or 18 months later * The change amount of the lumber vertebra bone density efficacy The change amount of the following item in before prescription starting and 3 or 6 or 12 or 18 or 24 months later * The lumber vertebra bone density * The hip joint whole bone density * The transcervical bone density * The hand bone density * The hip joint bone strength * The transcervical bone strength * Bone metabolism marker (P1NP and TRACP-5b) efficacy The occurrence rate of the following item in before prescription starting and 3 or 6 or 12 or 18 or 24 months later * New chinquapin body bone fracture * New non-chinquapin body bone fracture safety safety

Key inclusion & exclusion criteria

Age minimum20
Age maximum
GenderBOTH
Include criteriaI make the patient who fills all following standards the subject. 1) Japanese Society for Bone and Mineral Research A nuclear power plant, based on the check standard of the osteoporosis (revise in fiscal year 2012), a nuclear power plant, the patient diagnosed as osteoporosis. 2) the age of the time of the agreement merit, more than 20-year-old patient (I don't ask about the gender.) 3) the patient who is after menopause since putting it for the lady 4) the patient who could get documentary consent by free will of the back and the patient person himself which had the enough explanation in case of participation of this research
Exclude criteriaThe patient who conflicts in following one of them won't incorporate in this research. 1) the patient who has treatment reki of osteoporosis before agreement acquisition 2) patient with peptic ulcer 3) patient with abnormality of severe blood 4) patient with severe hepatopathy 5) patient with severe kidney trouble (patient of a creatinine clearance 35mL/min sheep rise) 6) patient with a severe heart malfunction 7) patient with operating during dental disposal or infection in the active mouth 8) the patient who has that in a dehydrating state (high fever, the high loose bowels and vomit, etc.) 9) patient of a hypocalcemia 10) patient with the medical history of the severe drug allergy 11) patient with aspirin asthma or its medical history 12) the female with during pregnancy or a pregnant possibility or lactating woman 13) additionally the patient who judged that a study person in charge was unsuitable as a subject of research person

Related Information

Contact

public contact
Name Kamagaya General Hospital Clinical research center
Address 929-6 Hatsutomi Kamagaya-City Chiba
Telephone 81 47 498 8266
E-mail chiken@kamagaya-hp.jp
Affiliation
scientific contact
Name Kamagaya General Hospital Clinical research center
Address 929-6 Hatsutomi Kamagaya-City Chiba
Telephone 81 47 498 8266
E-mail chiken@kamagaya-hp.jp
Affiliation